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Buffalo, N.Y.-based Pedia Parents was handed a Form 483 after a July inspection found the company lacked adequate procedures for supplier monitoring, design verifications and medical device reports (MDR), among other lapses.
The FDA has cleared three Polarean Xenoview imaging devices that work together to enable the company’s hyperpolarized gas blend contrast agent to deliver lung ventilation scans without the use of radioactive gas.
The FDA has granted Class II designations — with general or special controls to assure safety — for several categories of devices submitted to the agency through the De Novo review pathway.
The FDA sent a Warning Letter to RoyalVibe Health for unapproved ultrasound technology devices the company has not removed from the market and for continuing to market the products online.
The proposed European Artificial Intelligence Act (AIA) will impose an additional burden on the already limited number of notified bodies, resulting in delays in the marketing of new medical devices and technologies, the European Association of Medical Devices Notified Bodies (Team-NB) says.
The FDA has issued Florida-based test manufacturer Empowered Diagnostics a warning letter for distributing COVID-19 test kits without marketing approval, clearance, or authorization.
The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the drug-device combination a priority review.
Advanced Bionics has agreed to pay more than $12 million to resolve allegations that it made false claims in premarket approval applications (PMAs) for some of its cochlear implant processors, the Department of Justice said.